DOSAGE and Administration
OF MONJUVI + Lenalidomide1
Recommended dosage of MONJUVI and lenalidomide
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MONJUVI should be administered by a healthcare professional with immediate access to emergency equipment and appropriate medical support to manage IRRs
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The recommended dose of MONJUVI is 12 mg/kg based on actual body weight administered as an intravenous infusion according to the dosing schedule in the table below
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Administer MONJUVI in combination with lenalidomide 25 mg orally on days 1 to 21 of each 28-day cycle for a maximum of 12 cycles, then continue MONJUVI as monotherapy until disease progression or unacceptable toxicity
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Refer to the lenalidomide prescribing information for dosing guidelines and recommendations
Administration of MONJUVI
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Administer MONJUVI as an intravenous infusion.
For the first infusion, use an infusion rate of 70 mL/h for the first 30 minutes, then, increase the rate so that the infusion is administered within 1.5 to 2.5 hours
Administer all subsequent infusions within 1.5 to 2 hours
Infuse the entire contents of the bag containing MONJUVI.
Do not co-administer other drugs through the same infusion line.
No incompatibilities have been observed between MONJUVI with infusion containers made of polypropylene (PP), polyvinylchloride (PVC), polyethylene (PE), polyethylenterephthalate (PET), or glass and infusion sets made of polyurethane (PUR) or PVC.
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Cycle 1 | ||||||||||||||||||||||||||||
DAYS | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 | 18 | 19 | 20 | 21 | 22 | 23 | 24 | 25 | 26 | 27 | 28 |
MONJUVI 12 mg/kg | ■ | ■ | ■ | ■ | ■ | |||||||||||||||||||||||
Lenalidomide 25 mg daily | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | |||||||
Cycles 2 and 3 | ||||||||||||||||||||||||||||
DAYS | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 | 18 | 19 | 20 | 21 | 22 | 23 | 24 | 25 | 26 | 27 | 28 |
MONJUVI 12 mg/kg | ■ | ■ | ■ | ■ | ||||||||||||||||||||||||
Lenalidomide 25 mg daily | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | |||||||
Cycles 4 to 12 | ||||||||||||||||||||||||||||
DAYS | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 | 18 | 19 | 20 | 21 | 22 | 23 | 24 | 25 | 26 | 27 | 28 |
MONJUVI 12 mg/kg | ■ | ■ | ||||||||||||||||||||||||||
Lenalidomide 25 mg daily | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | |||||||
After 12 cycles, continue MONJUVI | ||||||||||||||||||||||||||||
monotherapy until disease progression | ||||||||||||||||||||||||||||
or unacceptable toxicity | ||||||||||||||||||||||||||||
DAYS | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 | 18 | 19 | 20 | 21 | 22 | 23 | 24 | 25 | 26 | 27 | 28 |
MONJUVI 12 mg/kg | ■ | ■ | ||||||||||||||||||||||||||
After 12 cycles, continue MONJUVI monotherapy until disease progression or unacceptable toxicity |
DAYS | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 | 18 | 19 | 20 | 21 | 22 | 23 | 24 | 25 | 26 | 27 | 28 |
MONJUVI 12 mg/kg | ■ | ■ | ||||||||||||||||||||||||||
RECOMMENDED PREMEDICATIONS1
Administer premedications 30 minutes to 2 hours prior to starting MONJUVI infusion to minimize IRRs. Premedications may include acetaminophen, histamine H1 receptor antagonists, histamine H2 receptor antagonists, and/or glucocorticosteroids.
For patients not experiencing IRRs during the first 3 infusions, premedication is optional for subsequent infusions.
If a patient experiences an IRR, administer premedications before each subsequent infusion.
IRR=infusion-related reaction.
DOSAGE MODIFICATIONS FOR ADVERSE REACTIONS1
Management guidelines for IRRs and myelosuppression
Infusion-related reactions (IRRs) | |
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Severity | Dosage Modification |
GRADE 2 (moderate) |
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GRADE 3 (severe) |
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GRADE 4 (life-threatening) |
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Myelosuppression | |
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Severity | Dosage Modification |
Platelet count of 50,000/mcL or less |
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Neutrophil count of 1,000/mcL or less for at least 7 days OR Neutrophil count of 1,000/mcL or less with an increase of body temperature to 100.4 °F (38 °C) or higher OR Neutrophil count less than 500/mcL |
|
CBC=complete blood count.
Refer to the lenalidomide prescribing information for lenalidomide dosage recommendations.
HOW MONJUVI IS SUPPLIED1
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MONJUVI (tafasitamab-cxix) for injection is a sterile, preservative-free, white to slightly yellowish lyophilized powder for reconstitution, supplied as a 200-mg single-dose vial
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Each 200-mg vial is individually packaged in a carton (NDC 73535-208-01)
STORAGE AND HANDLING OF MONJUVI1
Store refrigerated at 36 °F to 46 °F (2 °C to 8 °C) in the original carton to protect from light. Do not shake. Do not freeze.
REFERENCE: 1. MONJUVI Prescribing Information. Boston, MA: MorphoSys.